The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction

This study has been completed.

First Received on August 31, 2005. Last Updated on June 15, 2011 History of Changes

Sponsor:	Institut De Recherche International Servier
Information provided by:	Servier
ClinicalTrials.gov Identifier:	NCT00143507

Purpose

The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.

Condition	Intervention	Phase
Coronary Disease Ventricular Dysfunction, Left	Drug: Ivabradine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
Official Title:	Effects of Ivabradine on Cardiovascular Events in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction. A Three-year Randomised Double-blind Placebo-controlled International Multicentre Study.

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: S 16257

U.S. FDA Resources

Further study details as provided by Servier:

Primary Outcome Measures:

Composite endpoint including cardiovascular mortality, hospitalisation for acute myocardial infarction and for new onset or worsening heart failure.

Secondary Outcome Measures:

Composite and non-composite endpoints including hospitalisation for acute coronary syndrome, coronary revascularisation and mortality.

Estimated Enrollment:	10000
Study Start Date:	December 2004
Study Completion Date:	February 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Coronary artery disease
Left ventricular systolic dysfunction
Sinus rhythm: heart rate (HR) >= 60 beats per minute (bpm)

Exclusion Criteria:

Unstable cardiovascular condition
Severe congestive heart failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143507

Locations

United Kingdom
Royal Brompton National Heart and Lung Hospital
London, United Kingdom, SW3 6NP

Sponsors and Collaborators

Institut De Recherche International Servier

Investigators

Study Chair:

Kim Fox, MD

Royal Brompton National Heart and Lung Hospital

More Information

No publications provided by Servier

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. Epub 2008 Aug 29.

ClinicalTrials.gov Identifier:	NCT00143507 History of Changes
Other Study ID Numbers:	CL3-16257-056
Study First Received:	August 31, 2005
Last Updated:	June 15, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ventricular Dysfunction, Left
Ventricular Dysfunction

Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012